Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (CheckMate 568)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Non-Small-Cell Lung Cancer

Treatments: Biological: Ipilimumab; Drug: Platinum Doublet Chemotherapy; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02659059

CA209-568

Details and patient eligibility

About

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.

The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and Women ≥ 18 years of age
• Diagnosed with stage IV Non-Small Cell Lung Cancer
• Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.

Exclusion criteria

• Subjects with untreated CNS metastases are excluded.
• Subjects with carcinomatous meningitis
• Subjects with an active, known or suspected autoimmune disease.
• Subjects with a condition requiring systemic treatment with either corticosteroids ( > 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.
• Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.

Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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324 participants in 2 patient groups

Nivolumab+Ipilimumab

Experimental group

Description:

Part 1 Specified Dose on Specified Days

Treatment:

Biological: Nivolumab

Biological: Ipilimumab

Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy

Experimental group

Description:

Part 2 Specified Dose on Specified Days

Treatment:

Biological: Nivolumab

Drug: Platinum Doublet Chemotherapy

Biological: Ipilimumab